BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE

    MDR report key: 16563005 · Received March 17, 2023

    Report

    Report Number
    3008881809-2023-00138
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    January 9, 2023
    Report Date
    March 17, 2023
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    NJE
    PMA / PMN Number
    P180031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO THE AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE WAS NOT AVAILABLE; THEREFORE, A VISUAL INSPECTION AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND IT COULD NOT BE DEFINITIVELY DETERMINED IF THE DEVICE FAILED TO MEET SPECIFICATIONS BECAUSE THE PRODUCT WAS NOT RETURNED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTION FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER WAS THE DISTAL PORTION OF THE STENT DID NOT FULLY OPEN, CONSEQUENTLY IT WAS NOT WELL PLACED IN THE VESSEL TO BE IMPLANTED, THEREFORE, CONTINUING THE MANEUVER TO RELEASE THE STENT, AS IT WAS NOT WELL PLACED DISTALLY, THE DEVICE FELL INTO THE INSIDE THE ANEURYSM, WHICH WAS REMOVED AND ANOTHER SUCCESSFULLY IMPLANTED. IT WAS ALSO REPORTED THE DEVICE WAS PREPARED AS PER THE DFU, THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT. WHILE THERE ARE A NUMBER OF POTENTIAL CAUSES FOR THE REPORTED ISSUE, BECAUSE REVIEW AND ANALYSIS OF AVAILABLE INFORMATION FAILED TO IDENTIFY A DEFINITIVE CAUSE AND THE DEVICE WAS NOT RETURNED, AN ASSIGNABLE CAUSE OF UNDETERMINABLE WILL BE ASSIGNED TO THIS COMPLAINT. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING BRAIN ANEURYSM RECANALIZATION TREATMENT AT ACA (ANTERIOR COMMUNICATING ARTERY), THE DISTAL PORTION OF THE SUBJECT STENT DID NOT FULLY OPEN AS SHOWN IN IMAGING. CONSEQUENTLY, THE SUBJECT STENT WAS NOT WELL PLACED IN THE VESSEL TO BE IMPLANTED, THEREFORE, CONTINUING THE MANEUVER TO RELEASE THE SUBJECT STENT, AS IT WAS NOT WELL PLACED DISTALLY THEN THE SUBJECT STENT FELT INTO THE INSIDE THE ANEURYSM, WHICH WAS REMOVED. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546840 NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR CORK 21755580

    Patients

    Seq Age Sex Outcome Treatment
    1 Male EXCELSIOR SL-10 MICROCATHETER (STRYKER)| NEURON MAX CATHETER (PENUMBRA)| SOFIA CATHETER (MICROVENTION)| SYNCHRO2 GUIDE WIRE (STRYKER)| TRANSEND EX STANDARD GUIDEWIRE (STRYKER)